While policymakers in Congress are pushing the FDA to become more cautious in its approval of new drugs, this Journal
editorial reports a survey of physicians who think that, if anything, the FDA is already too cautious in its approval of new medicines.
The withdrawal of Merck's Vioxx from the market in 2004 led to Congressional demands for tougher FDA regulation and an explosion of litigation against the pharmaceutical industry. So it might interest readers to know that 80% of orthopedic surgeons surveyed in a new poll released by the Competitive Enterprise Institute think the painkiller should be back on the market.
That finding isn't all that surprising. These physicians work regularly with people suffering from chronic pain, specifically from arthritis for which there is usually no cure other than joint replacement. Trained in the vagaries of medical treatment, they also know that almost all drugs have risks. So they see no sound reason Vioxx should be ruled out as an option for patients who can't find relief elsewhere.
More broadly, the 175 orthopedic surgeons surveyed by the Polling Company for CEI seem to agree that the FDA is generally overcautious, not too lenient, when approving new drugs. Some 76% say the FDA approval process is "too slow"; 60% say that "on balance" FDA regulations "hinder" rather than help their ability to treat patients; and 70% said they favor changing the law so that unapproved therapies can be made available so long as they carry appropriate warnings about their status.
Lest anyone dismiss this survey as a oneoff, CEI has commissioned similar polls of the medical community in the past. A 2002 survey of oncologists found that 61% believed the FDA process was "too slow" and 68% wanted the ability to use unapproved therapies. And 70% of oncologists in 2002 and 78% of orthopedic surgeons in the new poll believe the public does not fully understand the "human cost" of FDA regulation"that is, that some people may suffer or die waiting for the FDA to act."